A single arm multicenter biomarker study determining the response to taxane-based chemotherapy in metastatic breast cancer patients with ESR1 mutations in cellfree DNA
Recruiting
- Conditions
- breast cancer, metastasis, ESR1 mutations, chemotherapy
- Registration Number
- NL-OMON25511
- Lead Sponsor
- Erasmus MC Cancer Institute, department of Medical Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 185
Inclusion Criteria
Female metastatic breast cancer patients with ER-positive, HER2- negative primary tumors;
- Previous treatment with at least an aromatase inhibitor either in adjuvant and/or metastatic setting;
Exclusion Criteria
- Previous chemotherapy for metastatic disease; completed within three years before inclusion
- Patients with locally advanced disease, primary not amendable for resection or
radiation therapy with curative intent;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish whether patients with ER-positive, HER2- negative MBC with an ESR1 mutation will benefit from taxane based chemotherapy, measured as progression free survival rate at 6 months.
- Secondary Outcome Measures
Name Time Method - To assess whether the efficacy and outcome on taxane based chemotherapy differ between ESR1 mutated versus wild-type patients.<br /><br>- To explore whether serial measurement of ESR1 mutations can predict survival and efficacy<br>of chemotherapy in patients with ER-positive, HER2-negative MBC.<br /><br>- To explore whether different activating ESR1 mutations (e.g. D538G and Y537S) display<br>differences in efficacy on chemotherapy.<br /><br>- To explore whether chemotherapy can result in loss of ESR1 mutations.<br /><br>- To explore whether other gene variants are associated with outcome to taxane-based treatment.